NCT05733169已完成不适用
Pre-calculation for Frequency Lowering With Hearing Devices
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.
研究概览
简要总结
Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experienced hearing aid user (minimum use duration 1 year)
- •Adult (minimum age: 18 years),
- •Experience with frequency lowering,
- •Hearing thresholds with N5-N7, S1, S2, S3 hearing loss
- •Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz) ,
- •Sensorineural hearing loss,
- •Air Conduction - bone conduction gap <= 10 dB,
- •Written and spoken German,
- •Ability to understand instruction,
- •Ability to describe listening experiences,
- •Ability to attend to the appointments,
- •Ability to fill in a questionnaire conscientiously
- •Healthy outer ear (without previous surgical procedures)
- •Hearing loss within the fitting ranges of the investigational product,
- •Informed consent as documented by signature.
排除标准
- •Clinical contraindications deformity of the ear (closed ear canal
- •or absence of pinna),
- •Not willing to wear the hearing aid,
- •Fluctuating hearing that could influence the results,
- •Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,
- •Limited mobility and not in the position to attend all appoint-ments,
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid,
- •Inability to produce a reliable hearing test result,
- •Massively limited dexterity,
- •Known psychological problems,
- •Known central hearing disorders.
研究组 & 干预措施
Hearing impaired group
Experimental
The hearing impaired group will compare the reference condition with the intervention condition.
干预措施: Frequency lowering intervention (Other)
Hearing impaired group
Experimental
The hearing impaired group will compare the reference condition with the intervention condition.
干预措施: Frequency lowering reference (Other)
结局指标
主要结局
Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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